Pharmaceutical Analysis Blog

Principles of HPLC Validation - Training Module 4: Quality by Design and Robustness

A short course in the systematic validation of HPLC methods. We introduce Quality by Design (QbD) as a laboratory lifestyle described in ICH Q8. QbD translates into more efficient method development, easier validation, more manageable methods in real applications, and higher quality data in the laboratory. 

This course is designed for laboratory personnel responsible for validating HPLC methods. It will also be useful for managers and quality assurance staff involved in the method validation process. For workers who develop, but do not validate methods, this class will give insight into how to develop methods that will be easier to validate. No prior experience is needed, although those with some laboratory experience will certainly benefit more than those with no experience at all.

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This course covers:

We introduce Quality by Design (QbD) as a laboratory lifestyle described in ICH Q8. QbD translates into more efficient method development, easier validation, more manageable methods in real applications, and higher quality data in the laboratory. We demonstrate QbD with two examples, one in the screening phase of method development, and one in the validation stage for a pharmaceutical product.

  • What is Quality by Design? 
  • Example I: QbD Screening Experiments
  • Example I: QbD Robustness Testing

By attending this online training course you will understand how to organize a validation project. By planning ahead, you will see how to develop better methods that will validate more easily and will function more reliably in routine use. You will realize how by using Quality by Design principles during development, the methods will be easier to validate and be more robust in routine use. You will learn how to decide which variables are important and which ones are not. You will see how software tools can help you to get much more mileage out of your experimental runs. You will gain a better understanding of the calibration process and how to examine data for problems. Learn when method adjustments are allowed without re-validating the method. Find out why uncertainty plays such a big role in validation.

You will be able to answer these questions upon completion of the course:

  • Describe the QbD?
  • What is the design space?
  • How is robustness related to QbD?
  • How does a description of the design space help the operator of an HPLC method?
  • How can screening experiments be helpful in developing a QbD method?
  • Describe how to set up screening experiments?
  • Describe the robustness testing during QbD?
  • Describe the experimental design for QbD robustness testing?
  • Why is a full factorial design useful for QbD assessment?
  • Why can the software designed to aid QbD assessment be more useful than manually running a factorial designed set of experiments and evaluating the data?

 

Principles of HPLC Validation - Available at USD125 Validate HPLC methods for  the analysis of pharmaceutical drug substance, drug product, impurities, and  degradation products.

 

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